Kornimate/medical-research-clean huggingface dataset:
real time optical coherence tomography (oct) of human tissue

Conditions: Breast Cancer

Summary: this is a single-arm, prospective, study of an optical imaging device on approximately twenty (20) subjects undergoing lumpectomies at one study site. in vivo and ex vivo imaging will be performed on study subjects with results being compared to final pathology.

this study is a single-center, prospective, two-part open label study of an optical imaging device on approximately twenty (20) subjects at one (1) study site. patients scheduled to undergo a lumpectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. the study period per subject is the time it takes to assess the in vivo and ex vivo breast tissue samples using the study device during their lumpectomy. all specimens will be marked with india ink and undergo standard post-operative histology, and digital histology images corresponding to the inked locations will be obtained. the images and the matched digitized post-operative histology images will then be randomized and read by a blinded, independent pathologist. sensitivity and specificity will be calculated.

Eligibility criteria:
inclusion criteria: 1. women 18 years of age or older 2. signed icf 3. women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery 4. planning breast preservation 5. patients undergoing lumpectomy (partial mastectomy) procedure exclusion criteria: 1. multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. neoadjuvant systemic therapy 3. all t4 tumors 4. previous radiation in the operated breast 5. prior surgical procedure in the same quadrant 6. implants in the operated breast 7. pregnancy 8. lactation 9. participating in any other investigational study for either drug or device which can influence collection of valid data under this study
risk of revision following knee arthroplasty in bariatric surgery patients

Conditions: Arthritis Knee; Bariatric Surgery Candidate; Prosthesis Failure; Prosthesis Survival; Prosthesis-Related Infections

Summary: previous studies have investigated the outcomes of knee arthroplasty (ka) following bariatric surgery (bas), but with substantial limitations as not stratifying for body mass index (bmi) at time of ka or not addressing the type of bas (gastric bypass, banding or sleeve). since bmi varies greatly in patients with previous bas, it is likely that bmi affects outcomes after ka in bas-operated patients. the investigators believe that stratifying for bmi would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after ka.


Eligibility criteria:
inclusion criteria: * primary knee arthroplasty due to osteoarthritis exclusion criteria: * primary knee arthroplasty due to traumatic osteoarthritis.

Keywords: arthroplasty revision bariatric
early connections, early detection and intervention in infants at risk for autism

Conditions: Autism Spectrum Disorder

Summary: early connections has two broad goals: * to identify risk indices for autism spectrum disorder (asd) in 6 to 24 month old infants who have an older sibling with asd or infants who have an older neurotypical sibling. * to assess whether it is possible to alter risk processes through early intervention with high-risk infants, thereby reducing social-communication delays or the severity of autism symptoms.

researchers at the university of washington want to learn more about the benefits of early monitoring and intervention for younger siblings of children with autism spectrum disorders (asd). the information gained in this study may improve methods of early detection and intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families. participants include families with a child who has been diagnosed with an autism spectrum disorder or typical development and a younger sibling 12 months old or younger. the study protocol includes: (1) comprehensive infant evaluations at the university of washington autism center at 6-months, 12-months, 18-months and 24-months of age. (2) developmental screening for the older sibling. (3) questionnaires and phone interviews for parents. (4) random assignment to an assessment and monitoring intervention group or a university of washington intervention group. all families will receive advice regarding appropriate intervention services. families who are assigned to the uw intervention will take part in a parent delivered intervention.

Eligibility criteria:
inclusion criteria: * older sibling with asd (biologically related to participant) * participant 12 months of age or younger * within 1 hour of university of washington * interested in participating in intervention exclusion criteria: * out of study area * serious parent substance abuse or psychiatric history * diagnosis of known genetic syndromes or neurological conditions (infant participant or older sibling) * serious motor impairment (infant participant) * significant prematurity (infant participant)

Keywords: infants risk markers erp parent child interaction promoting first relations social communication
anidulafungin pk in infants and toddlers

Conditions: Invasive Fungal Infections

Summary: this is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. there will be up to 24 subjects enrolled; each will receive anidulafungin. patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.plasma pharmacokinetics will be evaluated using a limited sampling scheme. we hypothesize that the pk parameters of anidulafungin will not differ from those observed in older children and adults.


Eligibility criteria:
inclusion criteria: * age \< 24 months at the time of enrollment * patient must have sufficient venous access to permit administration of study medication * infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry * availability and willingness of the parent/legally authorized representative to provide written informed consent. exclusion criteria: * patients with a history of anaphylaxis attributed to an echinocandin * any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study * previous participation in this study * previous exposure to an echinocandin in the month prior to study.
prophylactic norepinephrine infusion for spinal hypotension and inferior vena cava collapsibility index

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (ivc-ci).

post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. it affects nearly 50-60% of patients without appropriately treat. vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. the purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (ivc-ci).

Eligibility criteria:
inclusion criteria: * 18-45 years * american society of anesthesiologists physical status classification i to ii * scheduled for elective cesarean delivery under spinal anesthesia * full-term, singleton, pregnant women exclusion criteria: * height of no more than 150 centimeters * body weight greater than 100 kg or bmi greater than 30 * labor analgesia had been performed * contraindication of spinal or epidural anesthesia * eclampsia or chronic hypertension or baseline blood pressure ≥160mmhg * hemoglobin \<7g/dl * fetal distress or known abnormal fetal development * severe vascular disease * diabetes mellitus or cardiovascular disease or nervous system disease

Keywords: norepinephrine hypotension inferior vena cava collapsibility index cesarean delivery
postoperative cognitive dysfunction: correlations with olfactory dysfunction and related gene changes

Conditions: Postoperative Cognitive Dysfunction

Summary: to study on the postoperative cognitive dysfunction: correlations with olfactory dysfunction and related gene changes.to explore whether the olfactory dysfunction could be used as a predictor of pocd and to provide reference for pocd prevention, early detection and timely diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * between 60 to 85 years old; * undergoing non-cardiac and non-neurological surgery under general anesthesia; * expected hospital stay ≥5 days; * american society of anesthesiologists class i or ii. exclusion criteria: * mental or neurodegenerative diseases; * history of severe trauma or surgery within one year; * history of nasal or sinus illness or surgery; * cold or influenza within 3 weeks; * significant history of organ dysfunction; * previous neuropsychological testing; * difficulty to perform tests (including severe visual or auditory disorders); * mini-mental state examination (mmse) \<24 points, \<20 points if the participant only attended elementary school, or \<17 points if the participant did not go to school.

Keywords: non-cardiac surgery postoperative cognitive dysfunction
prevention of bacteremia induced by debridement of pressure ulcer

Conditions: Pressure Ulcers; Bacteremia

Summary: the purpose of this study is to analyse bacteremia induced by debridement of pressure ulcers in patients in the complex nursing department.


Eligibility criteria:
inclusion criteria: * patient in the complex nursing department * with contaminated pressure ulcers * going to have a debridement procedure exclusion criteria: * penicillin sensitivity * bacteremia that does not react to the antibiotic treatment

Keywords: debridement
characterization of the pharmacodynamic response to vaped thc

Conditions: Vaping; THC

Summary: this study aims to characterize the pharmacodynamic response to vaped thc in young adult, occasional cannabis users with respect to outcomes such as stimulation and sedative effects, mood, anxiety, and craving, as well as cognitive and objective outcomes such as heart rate and cortisol changes with thc vs placebo.

enrollees will include 120 healthy, weekly or greater mj users, aged 18-55. the study will be conducted according to a double-blind, placebo-controlled, random order, cross-over design, consisting of one 3-hour screening visit and 2 randomized, approximately 6-hour laboratory sessions. at the latter visits (following confirmation of eligibility), subjects will complete baseline questionnaires and assessments, including a driver simulator test, a blood draw, vitals, and an imaging session using functional near-infrared spectroscopy (fnirs). subjects will then vape a first dose (either thc or placebo based on randomization). vitals and questionnaires will then be administered throughout the visit, at baseline, and at approximately 15, 60, 90, 130, 165, and 210 minutes post initial dose. subjects will also perform fnirs testing at baseline, 30, and 180 minutes and driver simulator at baseline, 60, and 90 minutes post initial thc/placebo administration. a drug recognition expert (dre) will conduct a standard field sobriety test to identify impairment at approximately 130 minutes post dose. following the initial dose vaped at 0 minutes, standardized reduced doses will be vaped approximately 30, 60, and 90 minutes later. given the cross-over design of this study, participants will be assigned to receive thc or placebo at the first laboratory visit and will receive the other substance at the second laboratory visit.

Eligibility criteria:
inclusion criteria: * men and women aged 18-55 years, inclusive. * competent and willing to provide written informed consent. * able to communicate in english language. * regular, at least weekly on average, marijuana use * self-reported ability to abstain from cannabis for 24 hours without withdrawal. exclusion criteria: * any unstable, serious medical illness or cardiovascular disease/events. * new or unstable psychiatric symptoms, schizophrenia, or bipolar i disorder. * diabetes, cirrhosis, renal failure, hepatitis c, or hiv. * history of syncope without an identified situational stressor, migraines \>1x/month, or head injury with prolonged unconsciousness (\> 24 hours). * daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents. * current pregnancy, lactation or trying to become pregnant (confirmed by urine pregnancy test). * history of substance abuse treatment and intent to quit or receiving treatment for cannabis use. * affective disorder in the past month or history of panic attacks. * smoking more than 10 tobacco cigarettes or equivalent e-cigarettes a day. * in the opinion of the investigator, not able to safely participate in this study.

Keywords: vaping thc fnirs cannabis imaging
newborn pain and stress levels in oxytocin induction at birth

Conditions: Induced Vaginal Delivery

Summary: the aim of the study is to compare pain and stress levels in the early neonatal period in newborns with and without oxytocin induction. the research was conducted in a case-control study design. the population of the study consisted of participants who gave birth vaginally (with or without oxytocin induction). the sample number of the study was calculated with the g\*power 3.1.9.2 program, taking into account the mean and standard deviation values of the nips score in cetinkaya et al., (2020). effect size: 0.666, α= 0.05, power: 0.95, oxytocin induction group: 60, non-oxytocin induction group: 60. anticipating possible data loss, 164 participants and their newborns were included, 85 in the oxytocin induction group and 79 in the non-oxytocin induction group. was included. the data of the study were collected using the pregnant information form, neonatal follow-up form and newborn pain and stress assessment scale (alps-neo). the research data were analyzed in spss 29.0 (ibm) program.

purpose: to compare the pain and stress levels of painful stimuli in the early neonatal period in newborns with and without oxytocin induction. h1: there is a statistical difference between the alps-neo scores of the newborns of the group in which oxytocin induction was applied in labor and the group in which it was not applied. h0: there is no statistical difference between the alps-neo scores of the newborns of the group that underwent oxytocin induction in labor and the group that did not. the data of the study were collected using the pregnant information form, neonatal follow-up form and newborn pain and stress assessment scale (alps-neo). in the study, participants were divided into two groups: those with and without oxytocin induction, and the data were collected based on self-report. newborn painful stimuli were discussed under 3 headings; drying process, first injection process and blood sugar measurement process. before, during and after these procedures, data were confirmed and collected by one researcher and the other by an independent observer. statistical analysis was performed using ibm spss statistic 29.0 (ibm corp., armonk, ny, usa). descriptive statistical methods (number, percentage, mean, standard deviation) were used to evaluate socio-demographic data. it was used in comparative analysis of the data (chi square, t test, etc.). p value was considered significant at p\<0.05.

Eligibility criteria:
inclusion criteria: * pregnant at term, * giving birth vaginally, * birth weight ≥2500gr, * participants with a single and healthy fetus and their newborns exclusion criteria: * mentally incompetent, * having a high-risk pregnancy, * those with risky newborns

Keywords: oxytocin labor newborn pain stress induced
potential improvements in emergency department care for cancer patients according to clinical staff

Conditions: Cancer; Emergencies

Summary: the goal of this single center prospective cross-sectional study is to identify the facilitators and barriers among caregivers in the emergency department that influence disposition of patients with solid and hematology malignancies. the main question it aims to answer is to categorize the facilitators and barriers identified by three groups of emergency department (ed) staff. participants will be asked for permission, afterwards a short interview will be held with the different ed caregivers (ed nurse, attending physician and supervising physician).

the goal of this to identify the facilitators and barriers among caregivers in the emergency department (ed) that influence disposition of patients with solid and hematology malignancies. participants will be asked for permission, afterwards a short interview will be held with the different caregivers (ed nurse, attending physician and supervising physician) in the ed. the interviews will be held in the order of the ed care pathway, meaning ed nurse first, treating physician second and supervising physician at last. the interviews will be conducted for every patient with each of the caregivers. each interview will be conducted after the caregiver has made the first examination of the patient. the interview focuses on several parts of the emergency care process: the first part is regarding the actions that are executed during an ed visit. we will establish which actions are executed and why. the second part is regarding the suspected outcome for the patient. the third part will be about any potential improvements to the emergency care process for the patient.

Eligibility criteria:
inclusion criteria: * patients with solid or hematological malignancies and receiving system therapy or having received systemic therapy within the last 3 months. * presented at or admitted from the emergency department for the oncology, hematology, neuro- or lung-oncology clinical unit. * awake and conscious. * possible to answer questions within the same shift / day after presentation in the ed. exclusion criteria: * \<18 years old. * only received a surgical intervention as cancer treatment. * not willing or able to give written informed consent.
premedication dyclonine improves visibility during bowel cleansing for colonoscopy

Conditions: Bowel Preparation Scale; the Amount of Air Bubble; Adenoma Detection Rate

Summary: in this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. group a patients (n = 300) used only 3l peg before colonoscopy. patients in group b (n = 300) were additionally advised to dyclonine hydrochloride mucilage plus 3l peg, the overall quality of colonoscopy cleaning was evaluated using the boston bowel preparation scale by a single endoscopist who was blinded to the intervention. visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (adr). difficulty of procedure, and adverse events were also evaluated.


Eligibility criteria:
inclusion criteria: 1. patients are between 18-75 years old 2. undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up exclusion criteria: 1. suspected gastrointestinal obstruction or perforation 2. severe acute inflammatory bowel disease 3. toxic megacolon 4. ileus or gastric retention, ileostomy, 5. hypersensitivity to any of the ingredients 6. pregnancy and lactation and/or at a risk of becoming pregnant
wearable activity tracking to curb hospitalizations

Conditions: Hematopoietic Neoplasm; Malignant Solid Neoplasm; Lymphatic System Neoplasm

Summary: this study is being done to collect patient generated health data to predict the risk of patients needing emergency department visits or hospitalization before, during. and after receiving radiation therapy.

primary objective: i. validate a previously developed step-count model for predicting all-cause acute care (pooled across all devices). secondary objectives: i. validate a previously developed model for predicting each ed visits or hospitalizations during external beam rt using continuous step counts before, during, and after treatment. ii. validate the previously developed step-count model for predicting all-cause acute care for each of the two different device platforms. iii. validate concordance of step counts across each of the device's platforms in the apple group. iv. validate the previously developed shield-rt electronic health record (ehr)-based model for predicting unplanned acute care (ed visit or hospitalization). exploratory objectives: i. refinement of the pre-existing models(step count and shield-rt). ii. evaluate association between wearables collected parameters, ehr-based variables, and acute care events. iii. develop and validate a multi-modal predictive model for predicting acute care. outline: this is an observational study. participants are assigned to 1 of 2 groups. * group i: participants receive fitbit device and undergo non-interventional, standard of care, radiation therapy. * group ii: participants receive fitbit device and utilize their own personal apple healthkit-based device and undergo non-interventional, standard of care, radiation therapy.

Eligibility criteria:
inclusion criteria: * age \>= 18. * eastern cooperative oncology group (ecog) performance status =\< 2. * able to understand study procedures and to comply with them for the entire length of the study. * ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it. * diagnosis of invasive malignancy. * able to ambulate independently (without the assistance of a cane or walker). * planned treatment with fractionated external beam radiotherapy over at least 5 days (no fractional requirement). * not a previous participant on this protocol for subsequent courses. exclusion criteria: * participants bound to a wheelchair. * participants unable to ambulate independently (needing assistance of cane or walker).

Keywords: activity tracking hospitalization prevention artificial intelligence (ai) modelling